Regulatory affairs specialist (medical device-apac)

placeKuala Lumpur calendar_month 
We are currently looking for a Regulatory Affairs Specialist for one of a Medical Device MNC that specialises with surgical equipment. This position requires your urgent attention.
  • Reporting to: Regional RA Manager
  • Location: Kuala Lumpur
  • Excellent employee compensation and benefits
  • Work Type: On-site
the role
  • Prepare and support regulatory submissions of medical devices to health authorities, including assisting local partners.
  • Monitor and implement new or updated regulations impacting product registration and ensure regulatory databases are current.
  • Support internal teams (Sales, Operations, R&D) with regulatory guidance, maintain product registration processes, and participate in quality audits.
  • Manage medical device licenses, handle Field Service Notices with authorities, and ensure relevant standards are maintained and updated
the experience
  • Degree in engineering or life sciences preferred; other relevant degrees will be considered.
  • Demonstrated interest in regulatory affairs and quality management, with experience in APAC regulations being an added advantage.
  • Strong multitasking skills and ability to manage several projects simultaneously.
how to apply
Please apply to the job ad above.
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  • skills
no additional skills required
  • qualifications
no additional qualifications required
  • education

Bachelor Degree

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